UnknownPhase 3

A Trial Comparing Adjuvant Chemotherapy With Observation After Concurrent Chemoradiotherapy of Cervical Cancer (With Pelvic or Para-aortic Node Involvement)

China432 participantsStarted 2018-03-01

Plain-language summary

Cervical cancer with pelvic or para-aortic node involvement has a poor prognosis. Despite low-quality data, the routine practice to treat these patients is radiation with concurrent cisplatin. The aim of this study is to compare systemic chemotherapy with observation after radiation with concurrent cisplatin of cervical cancer ( with pelvic or para-aortic node involvement) for incidence of adverse events and local recurrence rate.

Who can participate

Age range18 Years – 70 Years

SexFEMALE

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Inclusion criteria

✓. Pathologically diagnosed cervical cancer;
✓. pelvic or para-aortic lymph metastases, at least match one of following
✓. Stage IB1-IVA diseases (FIGO system ver. 2014) without treatment before;
✓. Karnofsky Performance Scores ≥ 70;

Exclusion criteria

✕. Patients with distant metastasis before or during radiotherapy
✕. Severe dysfunction of heart, lung, liver, kidney or hematopoietic system
✕. Severe neurological, mental or endocrine diseases
✕. History of other malignancies
✕. Those who are considered by the researchers unsuitable to participate -

What they're measuring

3-year progression-free survival (3y-PFS)

Timeframe: 3 years after the date of adjuvant chemotherapy completion

Trial details

NCT IDNCT03468010

SponsorSun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-01

Contact for this trial

Wei-jun Ye, M.D

86-13538799871 yewj@sysucc.org.cn

View on ClinicalTrials.gov More Cervical Cancer trials